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Phase II clinical trial determines the effectiveness and safety of the candidate drug in patients suffering from the condition the new drug is designed to treat.
The main question that is answered in phase II studies is: "What is the most effective dosage range and the drug safety within that range?"
Phase II studies enroll 100 to 300 subjects, and depending upon the type of investigational drug and the condition it treats, the trial lasts anywhere from six months to two years.
Phase 2 is sometimes further classified into 2a and 2b phases based on the type of trials:
Phase 2a assesses the amount of drug to be given to the subject for optimal results.
Phase 2b assesses the how well the drug works at the prescribed dosage levels.
Know more about the phases involved in clinical trials: http://www.crocareers.in
What else can I help you with?
What are phase daigram?
Phase diagram are also known as thermal equilibrium diagram or a consistutional diagram 1. Different uses of phase diagram are 2. prediction of phase 3. amount of phase 4.composition of phase
Why 2 phase induction motors are not used in industries?
A two-phase* system is archaic, and has been completely superceded by three-phase systems, so there is no demand for two-phase induction motors. (*A two-phase generator has two phase windings, displaced from each other by 90 degrees.)
What is the formula for calculate 3 phase power MVAR?
Q = 3 Vph Iph sin(phase angle) = 31/2 Vline Iline sin(phase angle)
How many diodes in full wave rectifier?
Depends on the number of phases.single phase uses 4 diodesthree phase uses 6 diodes
What will happen if 2 phase load is connected to generator?
There is no such thing as a two phase load any more. Any two legs from a three phase system are classed as single phase. If this single phase load is connected across the generator it will induce an imbalance in the output voltages of the generator. This is one reason that single phase loads on a three phase generator should be shifted around to find the best possible balance.
What is the difference between phase 2 phase 2a and phase 2b clinical trials?
Phase 2a Clinical Trials are pilot studies done on a relatively smaller number of patients(100-300) in order to judge the efficacy and safety of the investigational drug. Whereas Phase 2b Clinical trials are Pivotal studies, a well established controlled trails done on a larger number of patients in order to judge the efficacy and safety of the investigational drug.
Which type of clinical trials is used the least?
Phase IV trial
What are phase 2 b clinical trials?
Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)). Drug efficacy was usually studied in Phase III trials but the pressure to cut costs during the clinical trials process has increased the use of Phase IIB trials that can already give clues as to how effective the drug will be at treating a certain condition.
What is phase 2 testing?
Phase 2 testing is a crucial stage in clinical trials that evaluates the efficacy and side effects of a drug or treatment in a larger group of participants, typically ranging from 100 to 300 individuals. This phase aims to determine whether the treatment is effective for a specific condition and to further assess its safety profile. It follows successful Phase 1 trials, which primarily focus on safety and dosage. Phase 2 results help inform the decision to advance to Phase 3 trials, where the treatment is tested in a larger population.
What phase in the development of pharmaceutical drugs is the drug tested on healthy human volunteers to test for toxicity and the body's handling of the drug?
phase I clinical trials
Clinical trials have how many phases?
Clinical trials typically have four phases: Phase 1 involves small groups of healthy volunteers to assess safety and side effects; Phase 2 involves a larger group to see if the treatment works; Phase 3 involves an even larger group to further evaluate efficacy and monitor side effects; and Phase 4 occurs after the drug has been approved and involves long-term monitoring.
When are drugs tested on humans?
After clinical animal trials at: Phase 1 - small group of healthy volunteers are tested
What is Clinical Trails?
Clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related involvement to evaluate the effects on health outcomes. Clinical research trials may be conducted by government health agencies such as NIH (National Institute of Health), researchers affiliated with a hospital or university medical program, independent researchers, or private industry. Clinical trial interventions include but are not restricted to: Experimental Drugs Cells and Other Biological Products Vaccines Medical Devices Surgical and Other Medical Treatments and Procedures Psychotherapeutic and Behavioural Therapies Health Service Changes Preventive Care Strategies and Educational Interventions. Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease. Types of Clinical TrialsThere are two main types of clinical trials: Observational clinical trials do not test drugs or treatments. Researchers observe participants by monitoring their health over a period of time. These studies provide researchers with data that advances our understanding of Parkinson’s and how to treat the disease. Interventional clinical trials test the safety and effectiveness of a candidate drug, therapy or experimental treatment. Clinical trials also can be classified as follows: Treatment trials Prevention trials Screening trials Quality of Life trials Genetics trials Phases in Clinical Trials: Phase 0: Number of Subjects (10-15) Phase I: Screening for safety: Number of Subjects (20-80) Phase II: preliminary efficacy of the drug: Number of Subjects (100-300) Phase III: Final confirmation of safety and efficacy: Number of Subjects (1000-3000) Phase IV: Post marketing studies.
Are there clinical trials for Dandy-Walker syndrome?
There are no clinical trials for Dandy-Walker syndrome
What has the author Tom Brody written?
Tom Brody has written: 'Clinical trials' -- subject(s): Research Design, Clinical Trials Data Monitoring Committees, Drug Approval, Clinical Trials as Topic, Clinical trials, Drug approval
Phase 4 of Clinical Trials and the New Drug Application may take years to monitor durability of response?
5 to 10 years
Stakeholders in clinical trials?
Clinical trials are experiments to find out how effective a drug is, and if there are any side effects. The stakeholders in clinical trials are the patients, doctors, drug companies, drug manufacturers, and pharmacists.
